A drug in a vial container is generally in powder form. When administering this drug to a patient, a solution is injected into the vial container to dissolve the drug and obtain a drug solution, and then the drug solution is transferred to a drug solution bag. The amount of drug solution transferred to the drug solution bag needs to be measured appropriately according to the patient's physique.
There are cases where the drug stored in the vial container is a drug designated as a dangerous drug, such as an anticancer drug. It is necessary to avoid a situation where a drug solution that contains such a dangerous drug leaks out and comes into contact with the operator's finger or the like, or the operator inhales vapor from the liquid. Accordingly, it is desired that the above series of tasks including dissolving the drug in the vial container and transferring the drug solution to a drug solution bag is performed using a “closed-system device” that has a low possibility of the drug solution leaking.
A medical connector 900 shown in FIG. 33 (see Patent Documents 1 and 2) is known as one example of such a device. The connector 900 includes a first connector 910, a second connector 920, and a tubular portion 930 therebetween. The first connector 910 includes a male luer 911 that is inserted into a port 970 of a drug solution bag (not shown). The second connector 920 includes a bottle needle 921 that punctures a rubber plug 985 of a vial container 980. A liquid channel 922 for the flow of a liquid and a gas channel 923 for the flow of a gas (air) are formed independent of each other in the bottle needle 921.
The tubular portion 930 is approximately cylinder-shaped. An inner cavity 935 of the tubular portion 930 is in communication with the male luer 911 via a first hole 931 and a second hole 932. Also, the liquid channel 922 and the gas channel 923 of the bottle needle 921 are also in communication with the inner cavity 935 of the tubular portion 930. The first hole 931 and the liquid channel 922 are formed at positions that oppose each other in the inner circumferential face of the tubular portion 930. Also, the second hole 932 and the gas channel 923 are formed at positions that oppose each other in the inner circumferential face of the tubular portion 930.
A syringe 990 is connected to one end of the tubular portion 930. A stopcock 940 is inserted into the other end of the tubular portion 930. The stopcock 940 includes an insertion portion 946 that is inserted into the tubular portion 930 and an operation portion 947 that is exposed outside the tubular portion 930. By operating the operation portion 947, the stopcock 940 can be rotated while the insertion portion 946 is inserted into the tubular portion 930.
A first channel 941 and a second channel 942 are formed in the insertion portion 946. The first channel 941 puts the syringe 990 in communication with the first hole 931 or the liquid channel 922 depending on the position of the stopcock 940 in the rotation direction (in FIG. 33, the first channel 941 has put the syringe 990 and the liquid channel 922 in communication). When the first channel 941 puts the syringe 990 and the first hole 931 or the liquid channel 922 in communication, the second channel 942 puts the second hole 932 and the gas channel 923 in communication. A hydrophobic filter 950 is provided in the second channel 942. The hydrophobic filter 950 has the property of allowing gases to pass and not allowing liquids to pass.
A method for preparing a drug solution using the connector 900 configured as described above will be described below with reference to FIGS. 34 to 37. In FIGS. 34 to 37, the members other than the connector 900 are shown by dashed double-dotted lines in order to simplify the drawings.
First, as shown in FIG. 34, the connector 900 is held such that the drug solution bag (not shown) is at the top and the vial container 980 is at the bottom. The drug solution bag is a bag-like object obtained by sealing the outer peripheral edge portions of two flexible sheets. The vial container 980 is an airtight container made of a hard material such as glass. A solution for dissolving the powdered drug in the vial container 980 is stored in the drug solution bag. The first channel 941 of the stopcock 940 has put the syringe 990 and the first hole 931 in communication. The plunger (not shown) of the syringe 990 has been inserted to the maximum depth in the outer cylinder (not shown) of the syringe 990. The plunger of the syringe 990 is pulled in this state (see arrow P91). The solution in the drug solution bag passes through the male luer 911, the first hole 931, the first channel 941, and the inner cavity 935 of the tubular portion 930 in the stated order, and then flows into the syringe 990 (see arrow L91). The pull amount of the plunger is adjusted so as to transfer a predetermined amount of solution into the syringe 990. Since the drug solution bag undergoes deformation as the solution flows out, the air pressure inside the drug solution bag is kept constant. Since the hydrophobic filter 950 is provided in the second channel 942, even if the interior of the vial container 980 is at a negative pressure, the solution in the drug solution bag does not pass through the male luer 911, the second hole 932, the second channel 942, and the gas channel 923 in the stated order and flow into the vial container 980.
Next, as shown in FIG. 35, the stopcock 940 is rotated 180 degrees while keeping the orientation of the connector 900 the same as in FIG. 34. As a result, the syringe 990 and the liquid channel 922 are put in communication via the first channel 941 of the stopcock 940. The plunger (not shown) of the syringe 990 is then pushed in this state (see arrow P92). The solution in the syringe 990 passes through the inner cavity 935 of the tubular portion 930, the first channel 941, and the liquid channel 922 in the stated order, and then flows into the vial container 980 (see arrow L92). Since the vial container 980 is an airtight container, the interior of the vial container 980 becomes positively pressured as the solution flows in. For this reason, the air inside the vial container 980 passes through the gas channel 923, the second channel 942, the hydrophobic filter 950, the second hole 932, and the male luer 911 in the stated order, and then moves into the drug solution bag (see arrow G92). The air pressure in the vial container 980 is thus kept constant. The drug in the vial container 980 is dissolved by the injected solution, and a drug solution is obtained.
Next, as shown in FIG. 36, the connector 900 is inverted vertically such that the vial container 980 is at the top and the drug solution bag (not shown) is at the bottom, while keeping the direction of the stopcock 940 the same as in FIG. 35. The plunger (not shown) of the syringe 990 then is pulled in this state (see arrow P93). The drug solution in the vial container 980 passes through the liquid channel 922, the first channel 941, and the inner cavity 935 of the tubular portion 930 in the stated order, and then flows into the syringe 990 (see arrow L93). The interior of the vial container 980 becomes negatively pressurized as the drug solution flows out. For this reason, the air in the drug solution bag (not shown) passes through the male luer 911, the second hole 932, the second channel 942, the hydrophobic filter 950, and the gas channel 923 in the stated order, and then flows into the vial container 980 (see arrow G93).
Next, as shown in FIG. 37, the stopcock 940 is rotated 180 degrees while keeping the orientation of the connector 900 the same as in FIG. 36. As a result, the syringe 990 and the first hole 931 are put in communication via the first channel 941 of the stopcock 940. The plunger (not shown) of the syringe 990 is then pushed in this state (see arrow P94). The drug solution in the syringe 990 passes through the inner cavity 935 of the tubular portion 930, the first channel 941, the first hole 931, and the male luer 911 in the stated order, and then flows into the drug solution bag (not shown) (see arrow L94). The push amount of the plunger is adjusted so as to inject a predetermined amount of drug solution into the drug solution bag.
As described above, according to the conventional connector 900, the amount of solution injected into the vial container 980 and the amount of drug solution injected into the drug solution bag can be appropriately measured using the syringe 990. Also, the series of tasks for preparing the drug solution can be performed in the state in which the male luer 911 is inserted into the port 970 of the drug solution bag and the bottle needle 921 has punctured the rubber plug 985 of the vial container 980, and thus there is a low possibility of the dangerous drug solution and vapor therefrom leaking to the outside.